Forward-Looking Statements
This prospectus, including the documents that we incorporate by reference, contains predictive or “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of current or historical fact contained in this prospectus, including statements that express our intentions, plans, objectives, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “will,” “should,” “would” and similar expressions, as they relate to us, are intended to identify forward-looking statements.
These statements are based on current expectations, estimates and projections made by management about our business, our industry and other conditions affecting our financial condition, results of operations or business prospects. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed or forecasted in, or implied by, the forward-looking statements due to numerous risks and uncertainties. Factors that could cause such outcomes and results to differ include, but are not limited to, risks and uncertainties arising from:
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our cash position, our estimates and expectations regarding our capital requirements, cash and expense levels, liquidity sources, our need for additional financing and our ability to obtain, on satisfactory terms or at all, the financing required to support operations, research, development, clinical trials, and commercialization of products;
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a potential delisting of our common stock from trading on the Nasdaq Capital Market;
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our ability to continue as a going concern;
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the results and timing of our preclinical and clinical trial activities, including but not limited to our ability to enroll a sufficient number of patients timely to advance our clinical trials;
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our ability to expand our therapeutic candidate portfolio through internal research and development or the acquisition or in-licensing of intellectual property assets;
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the therapeutic benefits, effectiveness and safety of our therapeutic candidates;
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our ability to receive regulatory approval for our therapeutic candidates in the United States, Europe and other geographies;
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the expected regulatory approval pathway for our therapeutic candidates;
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potential changes in regulatory requirements, and delays or negative outcomes from the regulatory approval process;
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our reliance on third parties for the planning, conduct, management and monitoring of clinical trials, for the manufacture of clinical drug supplies and drug product meeting our specifications, and for other requirements;
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our estimates of the size and characteristics of the markets that may be addressed by our therapeutic candidates;
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market acceptance of our therapeutic candidates that are approved for marketing in the United States or other countries;
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our ability to successfully commercialize our therapeutic candidates, if approved for marketing;
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the safety and efficacy of therapeutics marketed by our competitors that are targeted to indications which our therapeutic candidates have been developed to treat;
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our ability to utilize our proprietary technological approach to develop and commercialize our therapeutic candidates;
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our heavy dependence on licensed intellectual property, including our ability to source and maintain licenses from third-party owners;